Associate Director, Regulatory Affairs Operations
AlkermesWaltham, Massachusetts, United States
Posted October 23, 2025
Full Time
About the Company
Alkermes is a pharmaceutical company specializing in the development of medicines for complex psychiatric and neurological disorders. With a portfolio of proprietary products and a pipeline of clinical candidates, Alkermes leverages its deep neuroscience expertise to address conditions often overlooked or stigmatized. The company's patient-inspired approach, integrated research strategy, and commitment to holistic support for patients and communities distinguish it in the industry.
Job Description
The Associate Director of Regulatory Operations will manage the full lifecycle of regulatory submissions, ensuring timely and compliant deliverables. This role involves supporting commercial portfolio activities, internal stakeholders, and systems implementation across the organization. Collaboration with regulatory affairs and cross-functional partners is crucial.
Requirements
- Lead end-to-end management of regulatory submissions.
- Oversee regulatory document management and submissions.
- Manage regulatory systems and subject matter expertise.
- Develop and implement submission improvement processes.
